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WALTHAM, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has completed the niraparib rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the maintenance treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy.

The niraparib NDA is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in patients who were assigned to one of two cohorts based upon germline BRCA mutation status, as determined by the Myriad BRACAnalysis CDx ® test. Within the cohort of patients who were not germline BRCA mutation carriers (non-gBRCAmut), tumor samples were assessed for HRD status using the Myriad myChoice ® HRD test.

The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both patient cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control. The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published simultaneously in The New England Journal of Medicine. Based upon the results of this trial, the indication proposed in the NDA provides for the use of niraparib regardless of tumor biomarker status, and it is anticipated that the BRACAnalysis ® CDx and myChoice ® HRD tests would be available to physicians as complementary diagnostics.

"TESARO is working daily to benefit the many women living with ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Our niraparib NDA and MAA submissions represent a significant step in our efforts to bring meaningful therapies to these patients."

AstraZeneca's Lynparza significantly delayed the recurrence of tumors in patients with ovarian cancer compared to a placebo, according to results from a phase III study announced by the company Wednesday.